The BioMedix PADnet Lab is a non invasive device used to record physiological data from the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures for use by the Physician in the identification of vascular pathology. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.

Device Description

The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use in the early detection of peripheral vascular disease. The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use by trained medical professionals in a hospital or clinic. It is not to be operated in an explosive atmosphere nor in the proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the PADnet Lab. The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements: Windows 2000 Operating System or higher, 128 MB RAM, 20 GB Free Hard Disk Space, 600 MHz Processor or higher.

AI/ML Overview

The provided document is a 510(k) premarket notification for the BioMedix PADnet Lab, which aims to demonstrate substantial equivalence to a predicate device, the Flostat Vascular Lab. This type of submission focuses on comparing the new device's characteristics and intended use to an already legally marketed device, rather than providing extensive clinical study data a standalone performance device. The document primarily highlights similarities and differences between the new device and the predicate device, emphasizing that the PADnet Lab's differences do not raise new safety or effectiveness concerns.

Therefore, many of the requested criteria, particularly those pertaining to acceptance criteria with reported performance, detailed study design, ground truth establishment, a human-in-the-loop study, or a multi-reader multi-case study are not typically part of a 510(k) submission for this type of device. The acceptance criteria in this context are primarily about demonstrating equivalence to the predicate device in terms of technology, safety standards compliance, and intended use.

Here's the information that can be extracted from the provided document:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this 510(k) are implicitly based on demonstrating substantial equivalence to the predicate device (Flostat Vascular Lab) in various technical and operational aspects, and adherence to relevant safety standards. The document doesn't present a table of numerical performance targets with corresponding measured values for the PADnet Lab's diagnostic capabilities. Instead, it compares features.

Acceptance Criterion (Implicitly based on Predicate Device & Standards)	Reported Device Performance (PADnet Lab)
Intended Use	Same intended use: Non-invasive assessment of the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures to assist in the identification of vascular disease.
Pulse Volume Recording Mechanism	Plethysmograph (Same as predicate)
Segmental Pressure Flow Sensor	Oscillometric (Different from predicate's distal flow sensor, but deemed not to raise new safety/effectiveness concerns)
Patient Population	Male/Female Adult (Same as predicate)
Environment of Use	Hospital or Clinic (Same as predicate)
Power Source	AC converted to DC (Same as predicate)
Software Controls	Operator initiated (Same as predicate)
Cuff Deflation Rate	3-5 mm Hg/Sec (Same as predicate)
Operating Environment	0 to +40°C, 15-90% humidity (Same as predicate)
Storage Environment	-40 to +50°C, 5-95% humidity (Same as predicate)
Safety Standards Compliance	Yes (Tested to EN60601-1 Electrical Safety, ISO 10993-1 Biological evaluation)
EMC Compliance	Yes (Tested to EN60601-1-2 EMC)
Prescription Device	Yes (Same as predicate)
Cuff Bladder Deflation	Automatic (Same as predicate)
Inflation Method	Automatic (Same as predicate)
Cuff Sizes	Multiple (Same as predicate)
Clinical Reports Generated	Yes (Same as predicate)
Printed Reports Generated	Yes (Same as predicate)
Sterility	Supplied Non-Sterile (Same as predicate)
Physical Characteristics (Weight, Size, Data Acquisition)	PADnet Lab is lighter, smaller, and uses single-site data acquisition (Differences noted but argued not to affect substantial equivalence).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail a specific "test set" in the context of clinical performance evaluation studies for the PADnet Lab. The submission is a 510(k) for substantial equivalence based on technical and functional comparison to a predicate device, along with adherence to recognized safety and EMC standards. Clinical data (e.g., from a test set of patients) for this specific device's diagnostic performance is not provided as the primary method to demonstrate substantial equivalence in this filing. The term "Clinical Reports" under the comparison table refers to the device's ability to generate such reports, not the submission of clinical study data for FDA review.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set with ground truth established by experts is described in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set and adjudication method are described in this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a "Blood Flow Monitor" and a "Plethysmograph", likely providing physiological measurements rather than interpretive "AI assistance" to human readers. No MRMC or human-in-the-loop study is mentioned.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. The PADnet Lab is a measurement device, not an "algorithm-only" or AI-driven diagnostic system in the sense of an imaging analysis tool. Its performance is based on the accuracy of its physiological measurements, for which a specific standalone performance study is not detailed here beyond compliance with general electrical and biological safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth is specified as no clinical performance study for diagnostic accuracy is detailed in this 510(k). The basis for "ground truth" in this context would implicitly be the validated performance of the predicate device and the accepted physiological principles behind plethysmography and oscillometric measurements.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device requiring such.

9. How the ground truth for the training set was established

Not applicable. No training set is discussed.

Summary

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K042616
page 1 of 5

OCT 1 2 2004

510(K) Summary of Safety and Effectiveness

General Information

Submitter's Name:	BioMedix, Inc.
Address:	4205 White Bear ParkwaySt. Paul, MN 55110
Telephone:	651-762-4010
Contact Person:	Will Rogers or Dick Magnuson
Date Prepared:	July 23, 2004
Registration Number:	2134492

Device

Name:	PADnet Lab
Trade Name:	PADnet Lab
Common Name:	Plethysmograph
Classification Name:	Blood Flow Monitor
Product Code:	JOM
Class:	II
Regulation Number:	870.2780

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K042614
page 2 of 5

Identification of Legally Marketed Devices

Name: Flostat Vascular Lab

K Number: K973644

Date Cleared: December 23, 1997

Description of the Device

The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use in the early detection of peripheral vascular disease. The PADnet Lab has been tested to the following standards.

EN60601-1 Electrical Safety .
EN60601-1-2 EMC .
. ISO 10993-1 Biological evaluation

The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use by trained medical professionals in a hospital or clinic. It is not to be operated in an explosive atmosphere nor in the proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the PADnet Lab.

The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements:

. Windows 2000 Operating System or higher
128 MB RAM .
20 GB Free Hard Disk Space t
600 MHz Processor or higher .

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Intended Use Statement

The BioMedix PADnet Lab is a non invasive device used to gauge the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures to assist in the identification of vascular disease. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.

Components/ Part Numbers

Description	BioMedix Part Number
1- USB cable	100-1600
1- Cuff kit	7200
BioMedix PADnet LabSoftware Program CD ROM	400-210
1-AC Power Cord	350-215
1- PADnet Lab Operators Manual	10650

Table of Comparisons

The following summary table of comparisons compares the new device (PADnet Lab) to the predicate device: Flowstat Vascular Lab.

#	Area	New Device: PADnet Lab	Predicate Device: FlowstatVascular Lab	Same	Different
1	Pulse VolumeRecording	Plethysmograph	Plethysmograph	X
2	Segmental Pressureflow sensor	Oscillometric	Distal Flow Sensor		X
3	Patient Population	Male/Female Adult	Male/Female Adult	X
4	Environment	Hospital or Clinic	Hospital or Clinic	X
5	Power Source	AC converted to DC	AC converted to DC	X
6	Weight	4 lbs.	26 lbs.		X
7	Data acquisition	Single site	Bilateral		X
8	Software Controls	Operator initiated	Operator initiated	X
9	Size	12 1/2"W X 10" D X 3 " H	20 1/2" W X 17 3/4 " D X 7" H		X
10	Cuff Deflation Rate	3-5 mm Hg/Sec	3-5 mm Hg/Sec	X

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K042616
page 4 of 5

11	Operating Environment	0 to +40°C 15 - 90%	0 to +40°C 15 - 90%	X
12	Storage Environment	-40 to +50° C 5-95%	-40 to +50° C 5-95%	X
3	Safety Standards	Yes	Yes	X
14	EMC	Yes	Yes	X
15	Prescription Device	Yes	Yes	X
16	Cuff Bladder Deflation	Automatic	Automatic	X
17	Inflation Method	Automatic	Automatic	X
18	Cuff Sizes	Multiple	Multiple	X
19	Clinical Reports	Yes	Yes	X
20	Printed Reports	Yes	Yes	X
21	Supplied Non-Sterile	Yes	Yes	X

Discussion of Similarities and Differences

The PADnet Lab and the Flowstat Lab have the following similarities:

Pulse Volume Recording .
Patient Population ●
Environment .
Power Source ●
Software Controls .
Cuff Deflation Rate .
Operating Environment .
Storage Environment .
Safety Standards .
. EMC
. Prescription Device
Cuff Bladder Deflation ●
Inflation Method .
Cuff Sizes .
. Clinical Reports
. Printed Reports
Supplied Non-Sterile .

The differences, with comments, are the following:

Segmental Pressure flow sensor The PADnet Lab uses Oscillometric not distal . flow sensor.
Weight PADnet Lab is significantly less. ●
Data acquisition -- PADnet Lab is single site not bilateral. .
. Size - PADnet Lab is significantly smaller.

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Thus, even though the PADnet Lab is not identical to the Flowstat Vascular Lab, we at BioMedix believe it should be granted substantial equivalence because:

It has the same intended use as the predicate device. .
It has the same technical characteristics as the predicate device and does not raise . any new types of safety or effectiveness concerns.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird in flight, composed of three curved lines. The text is arranged around the top and left side of the circle.

OCT 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomedix, Inc. c/o Ms. Laura Danielson 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891

Re: K042616

Trade Name: Biomedix PADnet Lab Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, pneumatic, or photoelectric plethysmographs Regulatory Class: Class II (two) Product Code: JOM Dated: September 22, 2004 Received: September 23, 2004

Dear Ms. Danielson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for woo bayed in to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou mayy are servisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or dayses to the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Ms. Laura Danielson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bhimma for
Drém D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Biomedix PADnet Lab

Indications for Use:

Callohis for Use.
The BioMedix PADnet Lab is a non invasive device used to record physiological data The DioModix PADmit Larterial system using pulse volume recordings and from the 10wer extremity artitis blood pressures for use by the Physician in the osentification of vascular pathology. It is intended to be used by healthcare identification of vasedial paintees.
professionals in a hospital or clinic environment. The device is not intended for professionals in a nebblished for use on or intended for use on or near non intact skin.

User Profile: Patient Population: Male/Female, Adults Environment of Use: Hospitals or Clinics

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Cardiovascylar Devices Division omber KO40616

Page of ______________________________________________________________________________________________________________________________________________________________________

(Posted November 13, 2003)

Regulation Number and Section

§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.

(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).